FDA Inspection
Dentatus Usa, Ltd.Dentatus Usa, Ltd. – FDA Inspection, Oct 13, 2016
Record Details
This FDA Inspection record concerns Dentatus Usa, Ltd., with an inspection on October 13, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1bcfb685-7a46-4eec-b0eb-eacae24066eb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 989331
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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